View All Letters to Agencies on Emerging Infections

IDSA comments on the CDC notice of proposed rulemaking for the control of communicable diseases, interstate and foreign. IDSA appreciates CDC working to codify and increase transparency around practices related to controlling communicable diseases, and provided recommendations as it moves forward.

IDSA responded to an FDA and NIAID request for public comments on how to improve clinical trial designs under the unique conditions in emerging infectious diseases. IDSA provided recommendations on addressing informed consent, striving for standard of care, and the importance of tailoring a clinical trial based on the specific circumstances of each outbreak as well as the intervention being studied.

IDSA responded to an HHS Notice of Proposed Rule Making to add influenza viruses that contain A/Gs/Gd/1/96 Hemagglutinin (HA), including wild-type viruses, as non-Tier 1 select agents and viruses that have additionally made transmissible among mammals by respiratory droplets in a laboratory as Tier 1 select agents. IDSA supported this proposal, and reaffirmed the importance of maintaining a balance between the public health risk of impeding research with these viruses against the public health risk of an accidental laboratory risk or act of bioterrorism.

IDSA submitted comments to the Assistant Secretary for Preparedness and Response (ASPR) on the agency's 2015-2018 draft National Health Security Strategy (NHSS). IDSA applauds the agency's comprehensive approach to national security and the inclusion of "One Health" principles in the strategy, while offering substantive comments on various components of the NHSS most relevant to ID physicians and their patients.

IDSA Supports the principles underlying the draft U.S. Government (USG) policy, but urges the USG to re-define the scope of oversight and provide much more specific guidance, analytical tools and other resources to assist institutions in implementation.

IDSA advocates balancing the public health risk of impeding the conduct of H5N1 research against the public health risk of an accidental laboratory release or act of bioterrorism. IDSA recommends that naturally occurring H5N1 viruses and vaccine strains be regulated as HHS select agents with current biosafety and biosecurity regulations, while H5N1 viruses that have been engineered for greater transmissibility or pathogenicity be regulated as Tier 1 select agents, and with increased biosafety and biosecurity restrictions.

IDSA conveyed its appreciation to CDC/HHS for aspects of the Proposed Rule that provide greater clarification for managing select agents and toxins. However, IDSA offered five overarching recommendations that improve biosecurity while taking into account the impact of regulations on research essential to public health and national security.

IDSA submitted comments to FDA on its revised influenza antiviral guidance, which has many improvements from the 2009 draft guidance. However, IDSA remains concerned with aspects of the document’s recommendations regarding study design for influenza treatment in uncomplicated illness and in hospitalized patients, as well as with its interpretation of the available clinical outcomes data.

In a letter to Commissioner Peggy Hamburg, IDSA requested a meeting with top agency officials to discuss issues and strategies related to novel H1N1 influenza, impediments to antibacterial drug development, strategies to better address antimicrobial resistance and the use of antimicrobials in animals.

In its comments, IDSA raised concerns about FDA's proposal to approve new antivirals for influenza based on superiority or dose-ranging trials vs. non-inferiority trials. IDSA also is concerned about FDA's adherence to Pediatric Research Equity Act requirements, which may act as an impediment to drug development in this critical area.

At a meeting of FDA advisory committee regarding development of an influenza antiviral home MedKit, IDSA provided public comments about the challenges to safe and effective use posed by the unknowns regarding use of current antivirals in a pandemic, combined with the absence of medical supervision in the proposed scenario of home based use.

IDSA, along with AMA, AAP, and AAFP, opposes federal plan to take a permissive approach to public purchase and home stockpiling of antivirals ahead of a potential influenza pandemic, citing clinical and public health considerations and the need for further study.

IDSA endorses the vaccine prioritization framework while also urging the federal government to create an integrated prioritization scheme across essential medical countermeasure including pandemic vaccine, pre-pandemic vaccine, antivirals and other countermeasures in order to rationalize pandemic response. IDSA likewise recommends establishment of a joint panel to reassess prioritization plans at the time of a pandemic, among other suggestions.

IDSA suggests that the federal government first focus on creating consistency among state antiviral stockpiles for treatment and secondly, focus on establishing stockpiles intended for the prophylaxis of the health care sector and essential emergency personnel.

IDSA supports an intensified U.S.-led effort to develop pandemic vaccine, coordinated through the Office of the Assistant Secretary for Preparedness and Response, to ensure the availability of an effective and available vaccine in the event of a pandemic.

Widespread use of a pandemic vaccine should be the central strategy for protection of human health during a pandemic event. National guidelines for prioritization of pre-pandemic and pandemic influenza vaccine are a critical component of this strategy.